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NCT04690751 · ClinicalTrials.gov registry record · Phase 1

Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet

A Phase 1 study, sponsored by SK Life Science.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT04690751: Completed Phase 1 study, sponsored by SK Life Science.

NCT04690751 is a Phase 1 study that has completed, run by SK Life Science. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04690751, a Phase 1 study, has completed, sponsored by SK Life Science.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

This study is designed to evaluate the relative bioavailability, or the degree and rate at which the drug is absorbed by the body of two cenobamate formulations (200 mg Oral Suspension and a 200 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the 200 mg Oral Suspension. This study will also look at the safety and tolerability of the oral suspension and the oral tablet under both fasted and fed conditions.

Primary Outcome

Maximum observed plasma concentration of cenobamate

Interventions

  • DRUG Cenobamate 200Mg Tab Fasted
  • DRUG Cenobamate Oral Suspension Fed
  • DRUG Cenobomate Oral Suspension Fasted

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2020-12-21
Est. Completion 2021-05-17
Phase Phase 1
SK Life Science

25 total trials

What the finished NCT04690751 record still lists

NCT04690751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 3 interventions - of which Cenobamate 200Mg Tab Fasted is the first listed.

NCT04690751 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04690751 about?

NCT04690751 is a clinical study titled "Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet". This study is designed to evaluate the relative bioavailability, or the degree and rate at which the drug is absorbed by the body of two cenobamate formulations (200 mg Oral Suspension and a 200 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the 200 mg Oral Suspensio...

What is the current status of trial NCT04690751?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-12-21. Estimated completion is 2021-05-17.

What interventions are being tested in trial NCT04690751?

The interventions under investigation include: Cenobamate 200Mg Tab Fasted (DRUG), Cenobamate Oral Suspension Fed (DRUG), Cenobomate Oral Suspension Fasted (DRUG).

Who is sponsoring clinical trial NCT04690751?

This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04690751's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04690751, the US trial registry maintained by the National Library of Medicine. NCT04690751 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.